Zenith Alpha Abdominal Endovascular Graft (2020-06-02)
- Starting date:
- June 2, 2020
- Posting date:
- June 19, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73373
Last updated: 2020-06-19
Affected Products
Zenith Alpha Abdominal Endovascular Graft
Reason
The affected lots may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the instructions for use.
Affected products
Zenith Alpha Abdominal Endovascular Graft
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- ZIMB-22-84
- ZIMB-24-70
- ZIMB-24-84
- ZIMB-24-98
- ZIMB-26-84
- ZIMB-26-98
- ZIMB-28-108
- ZIMB-28-128
- ZIMB-28-84
- ZIMB-28-98
- ZIMB-30-84
- ZIMB-30-98
- ZIMB-32-98
Companies
- Manufacturer
-
William Cook Europe A/S, A Cook Group Company
SANDET 6
BJAEVERSKOV
4632
DENMARK